Sr Principal Statistician

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

About the role

The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries. This role designs and reports Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician, responsible for all statistical aspects of study design, analysis, validation, and documentation. The Senior Principal Statistician provides statistical expertise to clinical development projects and develops statistical strategy, design, and analyses for clinical trials. This position collaborates with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations, and manages work done by external statistics and programming vendors.

Responsibilities

• Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• Collaborate with cross-functional team members to meet study and recurring report timelines.
• Support the development and implementation of study protocols.
• Review and provide input to data capture systems and participate in their validation.
• Develop statistical programs to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy, and validate analyses performed by statistical programming.
• Write statistical analysis plans, review plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses.
• Prepare for and attend meetings with regulatory agencies.
• Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices.
• Review timelines and analysis plans for CRO work to ensure timeliness and quality deliveries.
• Review and validate CRO deliverables.
• Act as the statistical subject matter expert with medical writers and other colleagues in the production of clinical reports, integrated summaries, and other documents.
• Respond to statistical questions from regulatory agencies.

Requirements

• Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, statistical principles and methodology, principles of statistical inference (hypothesis testing, deriving estimates), parametric and non-parametric models, principles of sample size calculations for comparing two arms, principles of design of experiments, and phase II-IV clinical trial data analysis.
• Experience in using SAS and R; knowledge of other statistical applications and programming languages is a plus.
• Knowledge of applicable regulatory requirements and guidelines (e.g., ICH Guidelines, drug development regulatory requirements as they relate to statistics, statistical contributions to marketing applications, and CDISC standards).
• Able to work in a fast-paced, flexible, team-oriented environment.
• Excellent interpersonal and communication skills (written and verbal).
• Strong attention to detail with a focus on delivering quality studies.
• Flexible, positive, creative thinker, and good communicator.
• Ability to work without close supervision and with well-developed time management skills.

Qualifications

• MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in the pharmaceutical or biotechnology industry.
• PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry.
• Knowledge of drug development regulations pertinent to statistical analysis.
• Knowledge of the oncology or hematology therapeutic area is preferred.
• Bayesian and adaptive design experience is preferred.
• Proficient SAS & R programming skills, solid understanding of CDISC models and standards.
• Excellent writing and communication skills, demonstrated leadership abilities, and excellent interpersonal skills.

Pay

The full and complete base pay range for this role is $156,000.00 - $234,000.00. Individual compensation paid within this range will depend on qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions.

Benefits

• Discretionary annual cash bonus or incentive compensation (depending on the role).
• Discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
• Medical, dental, and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.

For more information on benefits, visit Jazz Pharmaceuticals Benefits.